The FDA New Proposed Final Rule on Sunscreens: Summary of Proposed changes

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One needn’t be well acquainted with my blog to know that I’m not really a TLDR kind of girl. Yet, sometimes summarizing long things is helpful to people who don’t want to spend a weekend reading a 260 page document and check the footnotes. So, I’m going to go through the FDAs new proposed rule on sunscreens, and summarize each section into what I consider to be the big takeaways. The new proposed rule, in all its glory, can be read in full here. I highly recommend that one takes a look at the actual document. It’s long, but a good read.

This is intended to be part one in a series of posts on this new proposed rule, and is designed to be the most concise.

Introduction: Sunscreen Regulation.

In the United States, sunscreens are regulated as drug ingredients. This is to say, they are medicine, which prevent sunburn, skin photoaging, and the development of many skin cancers. The FDA advises that sunscreen be applied at a density of 2 milligrams per centimeter squared of skin every two hours, every day.

The FDA keeps track of all the rules about sunscreen, and their advisory regarding their use, on a document called a Monograph. This document contains information on:

  1. Acceptable Active Ingredients: which ingredients can be used, at which concentrations, in which combinations
  2. Uses: what the medication is meant to do // which diseases it treats
  3. Doses: How much of the medication to use: based in the active ingredients // based on the indication
  4. Formulations: In which vehicles the active ingredients can be delivered
  5. Labeling Requirements: What consumers need to know about the product, given the medication’s indication, as well as its ingredients, dosage, and formula.
  6. Testing Requirements: The requirements for the testing of the medication before it can be brought to market.
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Like all drugs, the FDA needs to have confidence that the medications are generally recognized as safe and effective (GRASE). This means they are:

  1. Effective treatments for their indicated use. In the case of sunscreens: they prevent sunburn, early skin aging, and some skin cancers.
  2. Be safe to use as directed. In the case of sunscreens: safe to be applied to one’s whole body, at a density of 2 milligrams per centimeter squared of skin, every two hours, every day of one’s life.

Based on recent research, and due to the Sunscreen Innovation Act of 2014, the FDA wants to make some changes to all aspects of the Monograph, and underscore that all sunscreen active ingredients are GRASE. The proposed rule seeks to address this.

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Sunscreen Active Ingredients

  • The FDA has reviewed the available literature on the active ingredients currently currently on the sunscreen monograph. Based on this literature, they have drawn the following conclusions:
  • Zinc Oxide and Titanium Dioxide are generally recognized as safe and effective at concentrations of up to 25%. This includes nanoparticles of those filters.
  • Trolamine Salicylate and PABA are not GRASE, and should be removed from the monograph.
    • In the case of Trolamine Salicylate, they cite the fact that it is an aspirin derivative, and can therefore have anti-colagulatory effects on the blood of those who use it topically, which can cause excessive bleeding.
    • In the case of PABA, they cite the fact that it has a high risk of allergy, especially when the filter has been degraded by sunlight.
    • They acknowledge that of the 700+ sunscreen companies surveyed, zero currently sell sunscreens containing either of those filters, so the proposed rule will have little to no impact on industry.
  • The FDA finds that it has insufficient data to make a GRASE determination on the following filters. The FDA makes clear that they are not claiming the filters are unsafe. They are calling for more data (in some cases, a lot more data).
    • Avobenzone
    • Cinoxate
    • Dioxybenzone
    • Ensulizole
    • Homosalate
    • Meradimate
    • Octinoxate
    • Octisalate
    • Octocrylene
    • Oxybenzone
    • Padimate O
    • Sulisobenzone
  • The FDA calls for research on all of these filters. It seeks to determine if the filters are absorbed through the skin to a concentration of .5 nanograms / ml of the bodily fluid tested. If they are, the FDA then requires research that indicates if there are any consequences to the filter’s absorption.
    • N.B.: Recent research (like, published this week) on Avobenzone, Octocrylene, and Oxybenzone sought to address the first part of this request, and found the filters did absorb through the skin. So, now those filters need to undergo further testing to show which, if any, effects the absorption of those filters may have.
  • This proposed rule does not address the new sunscreen active ingredients for which the Sunscreen Innovation Act sought approval, so the following are not covered in this proposed rule
    • Bemotrizinol (AKA Tinosorb S; INCI bis-ethylhexyloxyphenol methoxyphenyl triazine)
    • Bisoctrizol (AKA Tinosorb M; INCI methylene bis-benzotriazolyl tetramethylbutylphenol)
    • Drometrizole Trisiloxane (AKA Mexoryl XL)
    • Octyl Triazone (AKA Uvinul T 150; INCI Ethylhexyl Triazone)
    • Amiloxate, Diethylhexyl Butamido Triazone (AKA Uvasorb HEB AKA Iscotrizinol)
    • Ecamsule (AKA Mexoryl SX; INCI terephthalylidene dicamphor sulfonic acid)
    • Enzacamene (AKA 4-methylbenzylidene camphor)
    • I was surprised to see that Uvinul A Plus wasn't on this list...
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Formulae

  • The FDA will continue to allow sunscreens in the following forms: oils, lotions, creams, gels, butters (?? I’ve never seen a sunscreen butter), pastes, ointments, and sticks.
  • The FDA will also allow spray sunscreens, but makes clear they need to pass inhalation particle size & flammability testing.
  • The FDA finds that it has insufficient data on sunscreen powders, wipes, towelettes, body washes, and shampoos, and requests further data on these dosage forms prior to deeming them GRASE.
    • So, unless manufacturers provide data to show that sunscreen powders are effective and safe, the FDA will not include them on the final Monograph. In so doing, powders will not be able to be called sunscreens.

SPF & Broad Spectrum Labeling

  • The FDA proposes changing the maximum labeled SPF to 60+
  • The FDA will allow sunscreens up to SPF 80 (which will, obviously, be labeled as SPF 60+)
    • The FDA proposes 80 as the max SPF because (1) there is a lot of variability in high SPF sunscreens, so they don’t want the consumer to be misled (2) they don’t want consumers to use more sunscreen than they need.
  • The FDA proposes that in order to be sold as an SPF 15+, a sunscreen must be Broad Spectrum
    • This will ensure that all SPF 30s are unilaterally more protective than all SPF 15s.
    • The FDA is concerned that the current regulations allow for SPF 50s which are not Broad Spectrum, which provide less UV protection overall than Broad Spectrum SPF 15s (for example)
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The FDA is proposing an important and worthwhile change to the Broad Spectrum classification, wherein all Broad Spectrum Sunscreens must have a UVA I / UV ratio of 0.7 or higher.

  • Therefore, it should be understood that under these new guidelines, SPF should function to indicate the UVA protection as well as the UVB protection: as SPF increases, the UVA protection must also increase.
  • Currently, broad spectrum means that 90% of a product’s protection must be greater than or equal to 370 nm
  • This proposed regulatory framework is more similar to the EU guidelines, where there is an SPF number, and a UVA symbol meant to indicate that there is UVA protection equal to ⅓ of the indicated SPF, so an SPF 50 must have at least UVA protection of 16.7 (PA++++).
  • However, this approach is less transparent overall than the EU guidelines. The EU guidelines measure UVA against UVB, and the FDA proposes UVAI against UV generally.
  • Consumers in the US don’t have accurate PPD numbers on their sunscreens, which is to say, we can’t know what the equivalent PA rating would be – we’d need to know the protection against each wavelength of UV, calculate the mean absorbance, and measure that against the absorbance in the UVA I range, so unless sunscreen manufacturers provide this data, we remain in the dark regarding the specific UVA protection factor offered by the sunscreen.
  • This regulation seeks to make the selection of sunscreens easier for the consumer, as the regulation now says that if a product has a higher SPF, it must also offer more UVA protection that a product with a lower SPF.
  • Put another way: instead of having to look at two rating systems to determine a product’s protection (SPF & PA, for example), the FDA’s guideline means that an SPF 50 will have better UVA and UVB protection than an SPF 30, although the exact amount of UVA protection will not be indicated.
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Additional Labeling Requirements

  • The FDA proposal limits the SPF values which can be displayed. Instead of products with an “SPF 47” or “SPF 28,” sunscreens would be labeled: 15, 20, 25, 30, 40, 50, or 60+
    • If a sunscreen’s tested value is within two of the allowed label values, the lower one is to be selected (an SPF 49 will be labeled SPF 40).
  • The FDA wants all sunscreens to change their packaging, so they display [active ingredients and their percentage] + “Sunscreen” + [cream, spray, etc].
    • They later indicate this label should be in boldface type, which is just so silly to me. Not every typeface has a bold face, FDA!

Recordkeeping Requirements

  • The FDA wants companies to keep records of testing on their sunscreens from the time a formula is released until it has been 3 years since a formula with that label has been distributed.
  • This rule doesn’t really impact consumers.

Sunscreen + Insect Repellent Products:

  • The FDA proposes banning sunscreen + insect repellant sprays, and has some snarky reads about how these products should never have been brought to market to begin with.

More detail and my robust commentary will follow in due course!